QA Investigation Results

Pennsylvania Department of Health
ELIZABETHTOWN DIALYSIS
Health Inspection Results
ELIZABETHTOWN DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based on the findings of an on-site, unannounced Medicare recertification survey conducted August 31, 2020 through September 2, 2020, Elizabethtown Dialysis, was found to have the following standard level deficiencies that were determined to be in substantial compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.








Plan of Correction:




494.62(d) STANDARD
EP Training and Testing

Name - Component - 00
403.748(d), 416.54(d), 418.113(d), 441.184(d), 460.84(d), 482.15(d), 483.73(d), 483.475(d), 484.102(d), 485.68(d), 485.625(d), 485.727(d), 485.920(d), 486.360(d), 491.12(d), 494.62(d).

*[For RNCHIs at 403.748, ASCs at 416.54, Hospice at 418.113, PRTFs at 441.184, PACE at 460.84, Hospitals at 482.15, HHAs at 484.102, CORFs at 485.68, CAHs at 486.625, "Organizations" under 485.727, CMHCs at 485.920, OPOs at 486.360, and RHC/FHQs at 491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.

*[For LTC facilities at 483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually.

*[For ICF/IIDs at 483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at 483.470(i).

*[For ESRD Facilities at 494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years.

Observations:


Based on review of facility policy and procedure, review of emergency preparedness binder (EPB), and interview with facility administrator (FA) it was determined the facility failed to ensure that quarterly emergency preparedness fire drills were performed for one (1) of one (1) EPBs reviewed. (EPB # 1)

Findings include:

Review of 'Fire Safety Preparedness' policy on September 2, 2020, at approximately 12:03 p.m. revealed, "TRAINING AND EDUCATION:...2. Fire and evacuation training and drills, refer to policy: Facility Emergency Management Plan and Emergency Preparedness Drills: a. Required on a QUARTERLY basis. b. Each shift of patients...g. Document Emergency Exercise Template..."

Interview with FA on September 2, 2020 at approximately 1:23 p.m. revealed, "I know we did complete them but I can't find them."

No documentation provided to show quarterly fire drills performed in 2018, 2019 and first two quarters of 2020.

An interview with the Facility Administrator on 9/2/2020 at approximately 3:15 p.m. confirmed the above findings and confirmed the above policy as current.











Plan of Correction:

On 9/21/20 the FA or designee will inservice clinical teammates on Policy 1-04-01E, Arteriovenous Fistula (AVF) or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose and policy 1-05-01 Infection Control for Dialysis Facilities. Inservice included a focus on but not limited to; surveyor findings and the specific steps in policy 1-04-01 clarifying when to change gloves and when to preform hand hygiene between assessment of access and cannultion steps. Inservice included a review of; Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of glove, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area. Teammates will wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Gloves should be changed when: When going from a "dirty" area or task to a "clean" area or task.



The FA has reviewed policy 4-07-07 EMERGENCY PREPAREDNESS DRILLS and policy
4-07-04 FIRE SAFETY PREPAREDNESS with a focus on but not limited to; The FA, or designee, will maintain the emergency preparedness training and testing based on the facility Emergency Management Plan (EMP).
Fire safety drills:
b. Required on a QUARTERLY basis
c. One drill to be conducted for each shift of patients
d. Utilize Emergency Exercise Template "FIRE WITHIN FACILITY"
i. Emergency event drill template
ii. Drill evaluation
iii. Teammate attendance sheet
e. Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency
f. Document training for both teammates and patients
i. Patients use Reggie form Emergency Evacuation Acknowledgement Form
ii. Teammates use policy: Training/Inservice Documentation form

On 9/21/20, the FA will inservice all facility teammates on policies and complete the quarterly fire drills by September 30, 2020.
Inservices will be evidenced by Teammate attendance sheet. Evidence of patient fire drills will be documented on the patient emergency Evacuation Acknowledgement form. All documents

Including inservice record, patient acknowledgement form, Drill template and Drill evaluation will be filed in facility records.
The FA has calendared the remaining quarterly fire drills required for 2020.

To monitor for sustained compliance, the FA will review the completed quarterly fire drill documentation in
Monthly FHM with Medical Director. The FA is responsible for compliance with this plan of correction.

Completion date: 10/17/20




Initial Comments:


Based on the findings of an on-site, unannounced Medicare recertification survey conducted August 31, 2020 through September 2, 2020, Elizabethtown Dialysis, was found to have the following standard level deficiencies that were determined to be in substantial compliance with the requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.








Plan of Correction:




494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE

Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.




Observations:


Based on observations, review of facility policies and procedures, and interview with the Facility Administrator (FA), it was determined the facility failed to ensure the staff followed infection control protocols, including but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) ' Access of AV (arteriovenous) Fistula or Graft for Initiation of Dialysis ' observations (Observation # 2); and two (2) of four (4) treatment unit observations. (Treatment Unit Observations # 3 and #4)

Findings include:

Review of facility Policy:1-04-01E, 'Arteriovenous Fistula (AVF) or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose' on August 31, 2020 at approximately 1:25 p.m. section, ' Procedure ' states, " ...16. Remove gloves, perform hand hygiene and put on clean gloves prior to cannulation..."

Review of facility Policy: 1-05-01, ' Infection Control for Dialysis Facilities ' on September 1, 2020 at approximately 1:04 p.m. section, ' TEAMMATE HYGIENE ' states, " 1. Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area ... "

Observations conducted in patient treatment area on August 31, 2020 between approximately 10:29 a.m. - 4:04 p.m. revealed the following:

Observation #2: During observation #2 of 'Access of AV Fistula or Graft for Initiation of Dialysis' on 8/31/2020 at approximately 11:17 a.m. of patient #1, station/chair #12; Employee (Emp) #18 did not remove gloves and perform hand hygiene after evaluating access by locating/palpating cannulation sites and before applying antiseptic to skin over cannulation sites.

Treatment Unit Observation # 3: During treatment unit observation on 8/312/2020 at approximately 10:40 a.m., Emp # 15 did not perform hand hygiene after setting up station/chair #6 and removing gloves and prior to answering telephone call at the nurse ' s station.

Treatment Unit Observation # 4: During treatment unit observation on 8/31/3030 at approximately 11:09 a.m., Emp # 18 did not perform hand hygiene after conducting pH and conductivity test on station/chair #6 and removing right hand glove and prior to typing on the computer within the station.


An interview with the Facility Administrator on 9/2/2020 at approximately 3:15 p.m. confirmed the above findings and confirmed the above policy as current.












Plan of Correction:

On 9/21/20 FA or designee will inservice, clinical teammates (TMs) on Policy 1-04-01E, Arteriovenous Fistula (AVF) or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose and policy 1-05-01 Infection Control for Dialysis Facilities.
Inservice included a focus on but not limited to; surveyor findings and the specific steps in policy 1-04-01 clarifying when to change gloves and when to perform hand hygiene between assessment of access and cannulation steps. Inservice included a review of; Hand hygiene is to be performed upon entering the patient treatment area, prior to gloving, after removal of gloves, after contamination with blood or other infectious material, after patient and dialysis delivery system contact, between patients even if the contact is casual, before touching clean areas such as supplies and on exiting the patient treatment area. Teammates will wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station, and will remove gloves and wash hands or perform hand hygiene between each patient and/or station. Gloves should be changed when: When going from a "dirty" area or task to a "clean" area or task.
Attendance sheet will be completed and maintained in TM Inservice binder by FA. To monitor for sustained compliance, the FA or designee will complete infection control audits daily X2 weeks, weekly x 2 weeks, then monthly. The FA will review audit results in monthly FHM with Medical Director. The FA is responsible for compliance with this plan of correction.



Completion date: 10/17/20



494.30(a)(1)(i) STANDARD
IC-IF TO STATION=DISP/DEDICATE OR DISINFECT

Name - Component - 00
Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
-- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient.
-- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient's station should be used only for that patient and should not be returned to a common clean area or used on other patients.



Observations:


Based on observations, review of facility policies and procedures and interview with the Facility Administrator (FA), it was determined the facility failed to ensure the staff disposed of, discarded, or dedicated items taken into the dialysis station for one (1) of two (2) observations (Obs) of the ' Initiation of Dialysis with Central Venous Catheter ' (Obs # 1); one (1) of two (2) observations of the ' Access of AV (arteriovenous) Fistula or Graft for Initiation of Dialysis ' (Obs # 2); and one (1) of two (2) observations of the ' Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft ' (Obs # 3)

Findings include:

Review of facility Policy: 1-05-01, ' Infection Control for Dialysis Facilities ' on September 1, 2020 at approximately 1:04 p.m. section, ' TEAMMATE/PATIENT SAFETY ' states, " ...25. Non-disposable items are to be disinfected between patients ...43... Only teammates with clean hands may remove items from the supply cart ...DIALYSIS STATION MANAGEMENT ...65. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. This includes items used on individual patients during peritoneal dialysis or home hemodialysis training and during clinic visits ... "


Observations conducted in the facility treatment area on August 31, 2020 between approximately 10:29 a.m. - 4:04 p.m. and on September 2, 2020 between approximately 9:02 a.m.- 1:44 p.m. revealed the following:

Observation #1: During observation #2 of ' Initiation of Dialysis with Central Venous Catheter ' on 9/2/2020 at approximately 2:03 p.m., patient #7 at station/chair #23, Employee (Emp) # 20 rolled a biohazard bin into the station during initiation of dialysis and did not externally disinfect biohazard bin prior to returning it to the common supply area.

Observation # 2: During observation # 2 of ' Access of AV Fistula or Graft for Initiation of Dialysis ' on 8/31/2020 at approximately 11:17 a.m. patient # 1 at station/chair # 12, Emp # 18 rolling a stool into the station during initiation of dialysis and did not externally disinfect rolling stool prior to returning it to the common supply area.

Observation # 3: During observation # 2 of ' Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft " on 8/31/2020 at approximately 3:02 p.m. of patient # 9 at station/chair 6, Emp # 19 did not externally disinfect temperature probe after using on patient and prior to returning it to the common supply area.

An interview with the Facility Administrator on 9/2/2020 at approximately 3:15 p.m. confirmed the above findings and confirmed the above policy as current.












Plan of Correction:

On 9/21/20 FA or designee will inservice clinical teammates (TMs) on Policy 1-05-01 Infection Control for Dialysis Facilities. Inservice included a focus on but not limited to; surveyor findings and non-disposable items are to be disinfected between patients. Items taken into the dialysis station will be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on another patient. This includes patients clinic visits. Teammates were instructed this includes non-disposable items taken into the patient station such as biohazard binds, rolling, stools temperature probes.
Attendance sheet will be completed and maintained in TM Inservice binder by FA.

To monitor for sustained compliance, the FA or designee will complete infection control audits daily x2 weeks, weekly x w weeks, then monthly. The FA will review audit results in monthly FHM with Medical Director. The FA is responsible for compliance with this plan of correction.


Completion date: 10/17/20



494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

(2) Evaluation of the appropriateness of the dialysis prescription,




Observations:


Based on observations, review of facility policies and procedures, review of patient treatment flow sheets, and an interview with the Facility Administrator (FA), it was determined the facility failed to ensure that the patient prescription was being implemented as ordered by the physician for three (3) of six (6) observations. (Observation #2, #4, and #6).


Findings include:

Review of facility Policy: 1-04-05, ' Blood Flow Problems ' on September 1, 2020 at approximately 2:04 p.m. section, ' Policy ' states, " ...2. If blood flow problem remains unresolved, notify licensed nurse 3. The licensed nurse will assess the patient, their vascular access and extracorporeal circuit for the above and include the following ...Assess the effectiveness of above interventions, determine need to reduce blood flow and extend treatment time, notify nephrologist for further evaluation and/or interventions. 5. Document findings and interventions in patient ' s medication record. "

On September 2, 2020 at approximately 12:16 p.m.- 12:25 p.m., the following prescription verification observations were conducted with a patient care technician:

Observation #2: A prescription verification was conducted on patient #5 at station
/chair # 9. The Hemodialysis treatment prescription flowsheet dated 9/2/2020 showed dialysate flow rate (DFR) as 800. DFR set during treatment was 600. No additional physician orders to change DFR.

Observation #4: A prescription verification was conducted on patient #14 at station
/chair # 13. The Hemodialysis treatment prescription flowsheet dated 9/2/2020 showed blood flow rate (BFR) as 400. BFR set during treatment was 365. No additional physician orders to change BFR.

Observation #6: A prescription verification was conducted on patient #4 at station
/chair # 2. The Hemodialysis treatment prescription flowsheet dated 9/2/2020 showed blood flow rate (BFR) as 400. BFR set during treatment was 380. No additional physician orders to change BFR.


An interview with the Facility Administrator on 9/2/2020 at approximately 3:15 p.m. confirmed the above findings and confirmed the above policy as current.






Plan of Correction:

On 9/21/20 FA or designee will inservice clinical teammates (TMs) on Policy 1-04-05 BLOOD FLOW PROBLEMS and 1-03-08 PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT. Inservice included a focus on but not limited to; teammates were provided with surveyor findings and that patient physician prescription orders must be followed including BFR and DFR. If the dialysis prescriptions is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.
Abnormal findings or findings outside of any patient specific physican ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or AHP if applicable) as needed of changes in patient status. All findings, interventions and patient response will be documented in the patient's medical record.








Attendance sheet will be completed and maintined in TM Inservice binder by FA.
To monitor for sustained compliance, the FA or designee will complete post treatment flow sheet audits. 10% audits daily x 2 weeks, weekly x 2 weeks, then monthly. The FA will review audit results in monthly FHM with Medical Director. The FA is responsible for compliance with this plan of correction


Completion date: 10/17/20



494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:


Based on medical record (MR) reviews, review of facility policies and procedures, and interview with the Facility Administrator (FA), it was determined the facility failed to ensure staff adhered to policies/procedures, including but not limited to initial registered nurse assessment for three (3) of five (5) MRs reviewed. (MR # 1, # 2, and # 5)

Findings include:

Review of facility Policy: 1-04-07, ' New Patient Pre-Treatment Evaluation ' on September 1, 2020 at approximately 2:30 p.m. section, ' Policy ' states, " 1. Registered Nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility ...4. This pre-treatment evaluation will be documented on the 1-03-07A New Patient Pre-Treatment Initial Nurse Assessment 0910rev0418 found in eP&P (electronic policy and procedures). "

Medical Record reviews conducted on September 1, 2020 at approximately 11:16 p.m.- 3:00 p.m., revealed the following:

MR# 1: Medical Record # 1 revealed that initial dialysis treatment was conducted on 7/13/2020 at 2:35 p.m. The initial RN assessment was conducted on 7/13/2020 at 3:30 p.m., 55 minutes after start of treatment.

MR# 2: Medical Record #2 revealed that initial dialysis treatment was conducted on 1/24/2020 at 2:01 p.m. The initial RN assessment was conducted on 1/24/2020 at 3:20 p.m., 79 minutes after start of treatment.

MR# 5 : Medical Record #5 revealed that initial dialysis treatment was conducted on 12/9/2019 at 9:21 a.m. The initial RN assessment was conducted on 12/9/2019. No time of initial RN assessment written on form.

An interview with the Facility Administrator on 9/2/2020 at approximately 3:15 p.m. confirmed the above findings and confirmed the above policy as current.





Plan of Correction:

On 9/21/20 FA or designee will inservice clinical teammates(TMs) on Policy 1-04-07, NEW PATIENT PRE-TREATMENT EVALUATION and 1-03-07A NEW PATEINT PRE-TREATMENT INTIIAL NURSE ASSESSMENT. Inservice included a focus on but not limited to; Registered (RN) as required by federal regulation will perfor an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility ... 4. This pre-treatment evaluation will e documented on the 1-03-07A New Patient Pre-Treatement Intial Nurse Assessment.
Attendance sheet will be completed and maintained in TM Inservice binder by FA.

To monitor for sustained compliance, the AA to audit all medical records of newly admitted patients within 24 hours of admission and report findings to FA. The FA will review audit results in monthly FHM with Medical Director. The FA is responsible for compliance with this plan of correction.


Completion date: 10/17/20